Phase Ia Clinical Trial of FLT3L-Fc Protein in Healthy Volunteers

A Phase Ia clinical trial evaluated the safety, pharmacokinetics, and pharmacodynamics of RO7497987 (FLT3L-Fc) in 44 healthy volunteers. The study used single and multiple ascending dose regimens ranging from 0.7 mg to 70 mg. It was conducted by Anthony J. Iacovelli and includes data on adverse events, dose-dependent immune cell expansion, and pharmacokinetic parameters.

Use Cases

• Analyze dose-dependent increases in FLT3L-Fc Cmax and AUCinf from pharmacokinetic data across 0.7–70 mg dose cohorts.
• Correlate treatment-related adverse events like myalgia, headache, and lymphadenopathy with specific dose levels (SAD or MAD).
• Model the expansion of dendritic cell subsets, including conventional and plasmacytoid DC, relative to administered RO7497987 doses.
• Compare safety profiles and adverse event grades between single ascending dose (SAD) and multiple ascending dose (MAD) participant groups.

Strengths

• Data originates from a registered Phase Ia clinical trial (ISRCTN92655801) with a defined protocol.
• Includes results from 44 healthy volunteer participants across multiple dose levels.
• Reports specific pharmacokinetic metrics (Cmax, AUCinf) and pharmacodynamic outcomes like DC subset expansion.

Limitations

• The dataset is a 2.1 MB DOCX file, which is a small, unstructured document format not optimized for direct analysis.
• Sample data and column structure are unavailable, requiring manual extraction of tabular information.
• Limited to a single, small Phase Ia study in healthy volunteers, not patient populations.

Provenance

Source

figshare, authored by Anthony J. Iacovelli.

Collection Method

Data collected from a Phase Ia clinical trial (ISRCTN92655801).

Time Range

Temporal coverage of the clinical trial is not specified in the input.

Freshness

Last updated on 2026-03-24.

Geography

Spatial coverage is not specified in the input.